The Role of HIF-2a in the Pathogenesis of Reflux Esophagitis

Not Applicable

Completed

• Conditions: Gastroesophageal Reflux Disease; Esophagitis; Reflux Esophagitis
• Interventions: Other: Cessation of Acid Suppressing Medications

• Registration Number: NCT01733810
• Lead Sponsor: Dallas VA Medical Center

Brief Summary

The purpose of this study is to determine the role of hypoxia inducible factor (HIF)-2a on the production of inflammatory cytokines that lead to reflux esophagitis.

Detailed Description

Reflux esophagitis is thought to be caused by gastric acid that refluxes into the esophagus, causing injury. Newer data suggest that reflux of gastric juice into the esophagus stimulates HIF-2a, which increases production of inflammatory cytokines. These cytokines are thought to lead to reflux esophagitis. The investigators plan to study the relationship of HIF-2a to inflammatory cytokines in patients with known gastroesophageal reflux disease and reflux esophagitis.

Study Timeline

• Study First Submitted: 2012-11-16
• Study First Submitted QC: 2012-11-21
• Study First Posted: 2012-11-27
• Study Start: 2013-02-01
• Primary Completion: 2015-07-31
• Study Completion: 2019-07-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• U.S Veteran
• History of Los Angeles Grade C erosive esophagitis

Exclusion Criteria

• Inability to provide informed consent
• Esophageal varices
• Warfarin use
• Coagulopathy that precludes safe biopsy of the esophagus
• Comorbidity that precludes safe participation in the study
• Allergy to fluorescein sodium
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Reflux Patients	Cessation of Acid Suppressing Medications	Patients with reflux and a prior history of reflux esophagitis are being enrolled. The intervention is cessation of acid-suppressing medications.

Primary Outcome Measures

Name	Time	Method
change in esophageal inflammation from baseline to 14 days	day 0 and day 14	inflammation of the squamous esophageal mucosa will be measured at baseline and at 14 days

Secondary Outcome Measures

Name	Time	Method
change in HIF-2a levels from baseline to 14 days	day 0 and day 14	Amount of HIF-2a present will be measured at baseline and at 14 days

Trial Locations

Locations (1)

Dallas VA Medical Center; 🇺🇸 Dallas, Texas, United States